Reference is made to FIG. 1, which illustrates the anatomy of a calcified aortic valve, ascending aorta and aortic arch. Calcifications may be embedded and/or superimposed on the valve leaflets, which are connected to the aortic wall just below the coronary ostia.
Reference is now made to FIG. 2, which illustrates an enlarged view of a calcified aortic valve. The leaflets create concave sinuses on their aortic aspect, just below the coronary ostia. Calcification can be either embedded or superimposed on the leaflets, making the leaflets thicker and less pliable. Specifically, calcification that occurs at the leaflet base, i.e., where the leaflet connects to the annulus or aortic wall, can significantly impair the mobility of the leaflet, very much like friction in a door-hinge.
Reference is now made to FIG. 3, which illustrates the anticipated effect of using a balloon valvuloplasty device (prior art) in order to dilate the valve. The balloon is not designed to fracture the calcification, and therefore produces only a limited “stretching” effect on the leaflets and annulus. Such a “stretching” effect may have limited effectiveness and durability, can potentially cause tearing of the fibrous tissue that makes up most of the leaflets, and might even press the calcification against the AV node, leading to pacing complications.
Reference is now made to FIG. 4, which illustrates a typical outcome in the prior art when implanting a trans-catheter stent-mounted valve inside a heavily calcified native valve (either with or without conventional balloon valvuloplasty as a preceding step). The heavy calcification on the native valve leaflets remains intact, preventing the implanted stent-mounted valve from fully expanding. When the implanted valve stent does not expand properly, the implanted valve cross-sectional area will be smaller, the coaptation of the implanted valve leaflets will be sub-optimal, and significant paravalvular leaks may occur due to the remaining gaps between the implanted valve stent and the native valve leaflets. Each and all of these factors might significantly sacrifice the short-term and long-term outcome of the trans-catheter valve implantation procedure.